Medasource · 1 month ago
EUDAMED Regulatory Specialist
United States
Contract
Remote
Entry, Mid Level
2+ years expMedasource is seeking a Regulatory Affairs Specialist with deep expertise in EUDAMED and EU MDR compliance within the medical device sector. This role involves designing and implementing sustainable EUDAMED strategies, managing registrations, and collaborating with cross-functional teams to ensure compliance with global standards.
Health CareMedical
Hiring Manager
Mahayla Jones
Responsibilities
Design and implement a sustainable EUDAMED strategy, including governance, data ownership, and process integration
Assess current-state EUDAMED and MDR processes and provide actionable recommendations for improvement
Support leadership with strategic regulatory insight aligned to MDR, EUDAMED, and global compliance expectations
Partner with Senior Regulatory leadership to ensure alignment with Mentor and Surgery-wide regulatory objectives
Manage initial and ongoing EUDAMED registrations, including legal manufacturer and obligation assessments
Conduct detailed reviews of regulatory documentation (DOCs) to identify updates, newly signed documents, and gaps
Translate regulatory documentation into structured, usable data for EUDAMED and MDRIM systems
Support MDR Information Management (MDRIM) activities and execution rollout
Maintain and update technical documentation to support EU MDR and global regulatory compliance
Collaborate with internal teams supporting scope list development and execution activities
Coordinate international registrations and work with global affiliates
Work cross-functionally with R&D, Quality, and Regulatory teams
Ensure end-to-end regulatory responsibility, including CMC considerations (as applicable), regulatory submissions and maintenance, US and CE submissions for new product development and approvals, and lifecycle management of marketed products
Operate independently in a fast-paced, evolving regulatory environment
Communicate clearly and effectively with leadership and execution teams
Collaborate with stakeholders including Regulatory leadership, CSS support, and cross-functional partners
Qualification
Required
Minimum 2+ years hands-on regulatory SME experience in medical devices
Demonstrated experience with EU MDR, US FDA, and global regulatory frameworks
Direct EUDAMED experience strongly preferred and considered a differentiator
Experience with Regulatory Information Management (RIM/MDRIM) systems
Medical device industry background; MedTech Surgery experience strongly preferred
Prior experience working for a competitor or within a large MedTech organization is a plus
Proven cross-functional collaboration with R&D, Quality, and Regulatory teams
Experience supporting international registrations and coordinating with global affiliates
End-to-end regulatory responsibility, including CMC considerations, regulatory submissions and maintenance, US and CE submissions, and lifecycle management of marketed products
Strong independent thinker and problem solver; able to assess ambiguity and propose solutions without heavy direction
Strategic mindset with tactical execution ability
Highly organized with strong attention to detail
Proficient in Excel and synthesizing data from multiple sources
Able to understand regulatory documentation and manipulate, translate, and apply the content effectively
Clear, concise communicator with leadership and execution teams
Ability to ramp quickly with minimal onboarding
Comfortable operating in a fast-paced, evolving regulatory environment
Demonstrated ability to deliver results where prior contractors struggled due to lack of independence or slow execution
Preferred
Direct EUDAMED experience strongly preferred and considered a differentiator
Medical device industry background; MedTech Surgery experience strongly preferred
Prior experience supporting Mentor or Johnson & Johnson MedTech is highly desirable
Candidates rolling off programs within Surgery or other MedTech regulatory teams are ideal
Company
Medasource
Medasource is a hospital & health care company specializing in population health management and clinical engineering services.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Abimbola ojo
EPIC OPTIME/ ANESTHESIA Consultant at Ascension
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